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BBL ™ VDRL Antigen BBL ™ VDRL Test Control Serum Set

8085886(07)2020-05 English

INTENDED USEBD BBL™ VDRL Antigen is recommended for use in the Venereal Disease Research Laboratory (VDRL)1 test for the detection of reagin, an antibody-like substance, by the qualitative and quantitative slide flocculation tests.BD BBL VDRL Test Control Serum Set is recommended for use in the quality control testing of BD BBL VDRL Antigen by the slide flocculation test.

SUMMARY AND EXPLANATION Treponema pallidum is the causative agent of syphilis. Syphilis is a chronic infection with many clinical manifestations which occur in distinct stages. Specific laboratory tests are recommended for the detection of each stage of the disease.2-4

The BD BBL VDRL Antigen is a nontreponemal antigen composed of cardiolipin, cholesterol and lecithin. The nontreponemal tests measure anti-lipid antibodies, which are formed by the host in response to lipids released from damaged host cells early in infection with T. pallidum, and lipid-like material from the treponemal cell surface.5 During syphilis infection, an antibody-like substance called reagin can be detected in the patient’s serum. In syphilis infection of the central nervous system, reagin can be detected in the cerebrospinal fluid (CSF).Reactive nontreponemal tests confirm the diagnosis in the presence of early or late lesion syphilis. They offer a clue in latent subclinical syphilis, and are effective tools for detecting cases in epidemiologic investigations. Nontreponemal tests are superior to the treponemal test for following the response to therapy.3Nontreponemal antigen tests are not entirely specific for syphilis, nor do they have satisfactory sensitivity in all stages of syphilis. Whenever the results of a nontreponemal antigen test disagree with the clinical impression, a treponemal antigen test such as the FTA-ABS2,3 should be performed. Nontreponemal tests such as the VDRL are used to screen patient serum, while treponemal tests such as the FTA-ABS are used for confirmation. The likelihood of obtaining a reactive VDRL test result in various stages of untreated syphilis has been reported as follows.3

Stages of Untreated Syphilis % Reactive VDRL TestPrimary 78

Secondary 100Latent 96Late 71

PRINCIPLES OF THE PROCEDUREIn the VDRL Test procedures, the patient’s serum is heat-inactivated and mixed with a buffered saline suspension of VDRL Antigen containing cardiolipin, lecithin and cholesterol. The combination of reagin and VDRL Antigen forms microscopic clumping called flocculation. With modification, the serum procedure can be used for testing CSF.1

REAGENTSBD BBL VDRL Antigen is 0.03% cardiolipin and 0.9% cholesterol dissolved in absolute alcohol with sufficient lecithin (approximately 0.20%) to produce standard reactivity. It is prepared with modifications according to the directions given by Harris, Rosenberg and Riedel.6 Cardiolipin and lecithin are prepared according to directions given by Pangborn.7,8,9 VDRL Buffered Saline is a 1% sodium chloride solution, pH 6.0 ± 0.1, with 0.05% formaldehyde as a preservative.Nontreponemal Antigen Reactive Serum is a lyophilized human serum with 0.1% sodium azide as a preservative which is standardized to provide a reactive reading when tested according to the USR or VDRL test procedure.VDRL Weakly Reactive Serum is a lyophilized human serum with 0.1% sodium azide as a preservative which is standardized to provide a weakly reactive reading when tested according to the VDRL test procedure.Nontreponemal Antigen Nonreactive Serum is a lyophilized human serum with 0.1% sodium azide as a preservative which is standardized to provide a nonreactive reading when tested according to the USR or VDRL test procedure.Warnings and Precautions: 1. For in vitro Diagnostic Use.2. WARNING: POTENTIAL BIOHAZARDOUS REAGENTS. Each donor unit used in preparation of BD BBL VDRL Test Control

Serum Set was tested by an FDA licensed method for the presence of the antibody to human immunodeficiency virus (HIV) as well as for hepatitis B surface antigen (HbsAg) and found to be negative (were not repeatedly reactive).

Because no test method can offer complete assurance that HIV, hepatitis B virus or other infectious agents are absent, these reagents should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological and Biomedical Laboratories, 2007.

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3. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. “Standard Precautions”10-13 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

4. BD BBL VDRL Antigen 240764 BD BBL™ VDRL Antigen; 1 x 5 mL Ampules with 1 x 60 mL Saline 240765 BD BBL™ VDRL Antigen; 10 x 0.5 mL Ampules with 1 x 60 mL Saline

Danger

H225 Highly flammable liquid and vapor. P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P241 Use explosion-proof electrical/ventilating/lighting equipment. P280 Wear protective gloves/protective clothing/eye protection/face protection. P240 Ground/bond container and receiving equipment. P233 Keep container tightly closed. P242 Use only non-sparking tools. P243 Take precautionary measures against static discharge. P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. P370+P378 In case of fire: Use for extinction: CO2, powder or water spray. P403+P235 Store in a well-ventilated place. Keep cool. P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

5. BD BBL VDRL Test Control Serum Set This Product Contains Dry Natural Rubber

WARNING: The control serum components contain sodium azide. Sodium azide is toxic by inhalation, by skin contact, and if swallowed. Contact with acid liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up. 235201 BD BBL™ VDRL Test Control Serum Set, 1 set of 3 vials: Nontreponemal Antigen Reactive Serum, one 3 mL vial VDRL Weakly Reactive Serum, one 3 mL vial Nontreponemal Antigen Nonreactive Serum, one 3 mL vial

Warning

H302 Harmful if swallowed. P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P301+P312 IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. P330 Rinse mouth. P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

Storage Instructions: Store BD BBL VDRL Antigen at room temperature (15–30 °C) in the dark.Store VDRL Buffered Saline at 15–30 °C. After bottle is opened, store at 2–8 °C.Store lyophilized control sera in the BD BBL VDRL Test Control Serum Set at 2–8 °C. Upon re-hydration of the control sera, store at 2–8 °C if contents will be consumed within one day. Alternatively, divide the control sera into aliquots sufficient for one day of testing and store at ≤ -20 °C.Do not use if reagents show signs of contamination, evaporation, precipitation or other signs of deterioration.

SPECIMEN COLLECTION AND PREPARATION1. Collect 5–8 mL of blood by aseptic venipuncture into clean, dry tube without an anticoagulant. 2. Allow blood to clot at room temperature, and centrifuge to obtain serum.3. Store serum specimens at room temperature for up to 4 h; after 4 h, store at 2–8 °C. Serum specimens may be refrigerated for

up to 5 days, then frozen at < -20 °C. Avoid repeat freezing – thawing of specimens. 4. Serum specimens must be clear, free of hemolysis and show no visible evidence of bacterial contamination (turbidity, hemolysis

or particulate matter). Refer to appropriate references for more information on collection of specimens.1,3,14

5. Before testing, heat the test sera at 56 °C for 30 min. Specimens that are not tested within 4 h must be reheated for 10 min. at 56 °C.

6. Specimens must be at 23–29 °C when tested.

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PROCEDUREMaterials Provided: BD BBL VDRL Antigen, VDRL Buffered Saline, BD BBL VDRL Test Control Serum Set.Materials Required But Not Provided: 0.9% Saline Nondisposable syringe, 1 cc Nondisposable calibrated needles without bevel: Serum test: 18 gauge CSF test: 21 or 22 gauge Bottles, 30 mL, round, narrow-mouthed, 35 mm in diameter with glass stoppers and a flat inner bottom surfaceNOTE: Properly washed 25 mL glass-stoppered Erlenmeyer flasks may be substituted if 30 mL bottles are not available. Micropipettor, 50 µLPipettes, serologic, graduated to tip: 1.0 mL, graduated in 1/100 mL 5.0 mL, graduated in 1/10 mL10.0 mL, graduated in 1/10 mL Slides: Serum test: 2 x 3 inches with paraffin or ceramic rings approximately 14 mm in diameter and high enough to prevent

spillage during rotation. CSF test: Kline concavity slides, 3 x 2 inches x 3 mm thick, 12 concavities measuring 16 mm in diameter and 1.75 mm

in depth.Slide holder for 2 x 4 inch slides Mechanical rotator adjustable to 180 ± 2 rpm, circumscribing a circle 19 mm in diameter on a horizontal planeWater bath, 56 °C Light microscope with 10× ocular and 10× objectiveSterile distilled or deionized waterAbsolute alcohol Acetone TimerReagent Preparation1. To rehydrate control sera in the BD BBL VDRL Test Control Serum Set, add 3 mL sterile purified water and rotate gently to

completely dissolve the contents. 2. Heat control sera at 56 °C for 30 min. Control sera that are not tested within 4 h must be reheated for 10 min at 56 °C.3. BD BBL VDRL Antigen and VDRL Buffered Saline are ready to use in preparing VDRL Antigen suspension. The VDRL Antigen

ampule has been pre-scored around the neck area, indicated by a visible band. Open the glass ampule by following the instructions below:a. Hold the ampule upright to allow the contents to settle into the bottom portion of the ampule, emptying the head space.

Tap the bottom of the ampule gently on a flat surface, if required.b. Slip the ampule opener (fins first) over the top of the ampule, pressing the opener downward until it rests on the shoulder of

the ampule; the fins should be located near or on the scoreline of the ampule.c. With one hand holding the bottom, use the other hand to grasp the opener, between the thumb and index finger. d. Snap the opener away from you using firm, even pressure.e. Discard the opener and ampule top. DO NOT REUSE THE AMPULE OPENER.

NOTE: The opened ampule may have sharp edges along the top where it separated. Do not touch this area.Preparation of Specific GlasswareWash syringes with needles and suspension bottles by hand in the following manner:1. Rinse with tap water.2. Soak and wash thoroughly in a glassware detergent solution.3. Rinse with tap water 6–8 times. 4. Rinse with unused distilled or deionized water. 5. Rinse with absolute alcohol.6. Rinse with acetone. 7. Air dry until acetone odor is completely eliminated.8. Remove needles from syringes for storage.

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Ceramic-ringed slides1. Rinse with tap water. 2. Wash with a glassware detergent solution.3. Rinse with tap water 3 to 4 times.4. Rinse with unused distilled or deionized water. 5. Wipe dry with lint-free cloth. If, after cleaning, the slide does not allow serum to spread evenly within the inner surface of the

circle, treat the slide as follows.6. Scrub the slides with a nonabrasive cleanser.7. Rinse, dry and polish with clean lint-free cloth.Avoid prolonged soaking of ceramic-ringed slides in detergent solution because the ceramic rings will become brittle and flake off. Test ProcedurePrepare the Antigen SuspensionCheck the pH of VDRL Buffered Saline at 25 °C before preparing VDRL Antigen suspension. Discard if outside the range of pH 6.0 ± 0.1.Allow VDRL Antigen and VDRL Buffered Saline to reach 23–29 °C before preparing VDRL antigen suspension. Use only suspension bottle with flat inner-bottom surfaces that allow the initial VDRL buffered saline to evenly cover the inner-bottom surface of the bottle. If the VDRL buffered saline beads or does not spread evenly to cover the bottom of the bottle, rewash the bottle as described above. (See NOTE above regarding use of 25 mL glass stoppered flasks). For reproducible results, the VDRL Antigen suspension must be checked daily for proper reactivity with BD BBL VDRL Test Control Serum Set. Only those VDRL suspensions producing the established reactivity pattern of the control serum should be used.1. Prepare a fresh VDRL antigen suspension each testing day. The temperature of the buffered saline, antigen and equipment

should be between 23–29 °C at the time the antigen suspension is prepared. 2. Pipette 0.4 mL of VDRL Buffered Saline to the bottom of a round, 30 mL glass-stoppered bottle with a flat inner-bottom surface.

Gently tilt bottle so that VDRL buffered saline will cover the entire inner-bottom surface of the bottle.3. Add 0.5 mL of BD BBL VDRL Antigen (from the lower half of a 1.0 mL pipette graduated to the tip) directly into the saline while

continuously but gently rotating the bottle on a flat surface. Add antigen drop by drop at a rate allowing approximately 6 s for 0.5 mL of antigen. Keep the pipette tip in the upper third of the bottle. Do not splash saline onto the pipette. The proper speed of rotation is obtained when the center of the bottle circumscribes a 5 cm diameter circle approximately 3 times per s.

4. Expel the last drop of antigen from the pipette without touching the pipette to the saline and continue rotation of the bottle for 10 s.5. Add 4.1 mL of buffered saline from a 5 mL pipette. Do not drop the saline directly onto the antigen; allow it to flow down the side

of the bottle.6. Cap the bottle and shake it from bottom to top and back approximately 30 times in 10 s. The antigen suspension is ready for

use and may be used during that day (8 h).7. Mix the VDRL Antigen suspension by gently swirling it each time it is used. Do not mix the suspension by forcing it back and

forth through the syringe and needle, since this may cause breakdown of particles and loss of reactivity.Test Accuracy of Antigen Suspension Needle for Serum Test1. The accuracy of the test depends on the amount of antigen suspension used. Check the calibration needle periodically to

ensure delivery of the correct volume of VDRL antigen suspension.2. For the qualitative and quantitative tests on serum, dispense antigen suspension from a syringe fitted with an 18 gauge needle

without bevel, which will deliver 60 ± 2 drops for antigen suspension per mL when held vertically.3. Place the needle on a 1 mL syringe. Fill the syringe with VDRL Antigen suspension. Holding the syringe in a vertical position,

count the number of drops delivered in 0.5 mL. The needle is correctly calibrated if 30 ± 1 drops are delivered in 0.5 mL.4. Replace the needle if it does not meet this specification. Repeat calibration on the new needle.VDRL Qualitative Slide Test on Serum1. Slide flocculation tests for syphilis are affected by the room temperature. For reliable and reproducible test results, the VDRL

Antigen suspensions, controls and test specimens must be at room temperature, 23–29 °C, when tests are performed.2. Pipette 50 µL of serum into one ring of paraffin or ceramic-ringed slide using a safety pipetting device. Do not use a glass slide

with concavities, wells or glass rings. Spread the serum with a circular motion of the pipette tip so that the serum covers the entire inner surface of the paraffin or ceramic ring.

3. Gently resuspend the VDRL Antigen suspension.4. Holding the VDRL Antigen suspension dispensing needle and syringe in a vertical position, dispense several drops to clear the

needle of air. Then add exactly one free-falling drop (17 µL) of antigen suspension to each circle containing serum. Do not allow the needle to touch the serum.

5. Place the slide on the mechanical rotator. Rotate the slide for 4 min at 180 ± 2 rpm. When performing the test in a dry climate, cover the slides with a moist, humidifying cover during rotation to prevent excessive evaporation.

6. Immediately after rotating the slide, remove it from the rotator and read the test results microscopically using 100× magnification.

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VDRL Quantitative Test on Serum1. To quantitate serum samples to endpoint titer, prepare serum dilutions on the slide at 1:1, 1:2, 1:4, and 1:8.2. Dispense 50 µL of 0.9% saline in circles numbered 2–4. Do not spread the saline. 3. Dispense 50 µL of serum in circle 1 and 50 µL of serum in circle 2.4. Mix the saline and the serum in circle 2 by drawing the mixture up and down in the pipette approximately 8 times. Avoid

forming bubbles.5. Transfer 50 µL from circle 2 (1:2) to circle 3 (1:4) and mix.6. Transfer 50 µL from circle 3 (1:4) to circle 4 (1:8), mix and then discard the last 50 µL.7. Gently resuspend the antigen suspension.8. Holding the antigen suspension dispensing needle and syringe in a vertical position dispense several drops to clear the needle

of air. Then add exactly one free-falling drop (17 µL) of antigen suspension to each circle.9. Place the slide on the mechanical rotator. Rotate the slide for 4 min at 180 ± 2 rpm. When performing the test in a dry climate,

place the slide under a moist, humidifying cover during rotation to prevent excessive evaporation.10. Immediately after rotation, read the test microscopically using 100× magnification.11. If the highest dilution tested (1:8) is reactive:

a. Prepare a 1:8 dilution of the test specimen by adding 0.1 mL of serum to 0.7 mL of 0.9% saline. Mix thoroughly.b. Place 50 µL of 0.9% saline into the second, third and fourth paraffin rings in a row on the slide. Prepare additional serial

dilutions for strongly reactive specimens.c. Add 50 µL of the 1:8 dilution of the test specimen to paraffin rings 1 and 2.d. Prepare serial twofold dilutions beginning with ring 2 and complete the test described above.

User Quality Control of VDRL Antigen Suspension1. Prepare a fresh antigen suspension each testing day. Once prepared, it should be used within 8 h.2. Use the prepared antigen suspension at 23–29 °C.3. Test antigen suspension reactivity with control sera (Reactive, Weakly Reactive and Nonreactive). 4. Use the antigen suspension only if it produces the expected reactivity with the control sera (Reactive, Weakly Reactive

and Nonreactive).Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory’s standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices.

RESULTS Qualitative1. Read and record results as follows: Medium to large clumps-Reactive (R) Small clumps-Weakly Reactive (WR) NO clumping or very slight roughness - Nonreactive (NR)2. Verify that the control sera results are as expected (Reactive, Weakly Reactive, Nonreactive). If reactions are not expected, the

test is invalid and results cannot be reported.3. Perform a quantitative test to endpoint on all serum specimens that produce Reactive, Weakly Reactive or “rough” Nonreactive

results in the qualitative slide test.QuantitativeReport the titer as the highest dilution that produces a Reactive (not Weakly Reactive) result. For example:

Serum DilutionsReport

Undiluted (1:1) 1:2 1:4 1:8 1:16 1:32R W N N N N Reactive, undilutedR R W N N N Reactive, 1:2 dilutionR R R W N N Reactive, 1:4 dilutionW W R R W N Reactive, 1:8 dilution

N (rough) W R R R N Reactive, 1:16 dilutionW N N N N N Weakly Reactive, undiluted

If reactive results are obtained through dilution 1:32, prepare further twofold serial dilutions in 0.9% saline (1:64, 1:128 and 1:256) and retest using the quantitative test procedure.

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Interpretation1. The results of the serum VDRL Test must be confirmed by a treponemal test. 2. The diagnosis of syphilis depends upon the results of the VDRL, treponemal confirmatory test, clinical signs and symptoms and

risk factors. 3. A reactive VDRL Test may indicate past or present infection with a pathogenic treponeme. However, it may be a false positive

reaction. A false positive is determined if the confirmatory treponemal test is negative. 4. A nonreactive VDRL Test with clinical evidence of syphilis may indicate early primary syphilis, a prozone reaction in secondary

syphilis, or late syphilis.5. A nonreactive VDRL Test with no clinical evidence of syphilis indicates no current infection or an effectively treated infection.6. A quantitative VDRL Test detects changes in reagin titer. Therefore, a serum specimen showing a fourfold increase in titer on a

repeat specimen may indicate an infection, a reinfection or a treatment failure. Likewise, a fourfold decrease during treatment indicates adequate syphilis therapy.

VDRL Test on Cerebrospinal FluidRefer to the appropriate reference for the procedure when testing cerebrospinal fluids with the VDRL Test.1

LIMITATIONS OF THE PROCEDUREA prozone reaction may occur in which reactivity with undiluted serum is inhibited. The prozone phenomenon often gives Weakly Reactive or “rough” Nonreactive results in the qualitative test. Therefore, all specimens with these results must be tested in the quantitative test.Biological false positive reactions can occur with nontreponemal tests in persons who abuse drugs, have diseases such as lupus erythematosus, mononucleosis, malaria, leprosy or viral pneumonia, or have recently been immunized.1Cross reactions may occur with other treponemal infections, such as yaws, pinta, bejel, or siti.In manufacturing, BD BBL VDRL Antigen is tested only with serum. For a modification of the serum test products and procedures for CSF testing, consult the appropriate reference.1 The user is responsible for modifying the products and procedures and for the required quality control standards.If the temperature of the testing area, specimens or reagents is less than 23 °C, test reactivity is decreased; if the temperature is greater than 29 °C, test reactivity is increased.1Test results are unpredictable when testing hemolyzed, contaminated or extremely turbid serum specimens. Plasma is not an acceptable specimen.For correct test results, strictly adhere to correct speed and length of time for rotating the specimens and antigen.

PERFORMANCE CHARACTERISTICS15,16

The performance of the VDRL slide test was compared to two rapid plasma reagin (RPR) card tests and a fluorescent treponemal antibody absorption (FTA-ABS) test for the diagnosis of syphilis in a study by Perryman, Larsen, Hambie, Pettit, Mullally and Whittington.15 Fresh serum samples obtained from 505 individuals were tested using these four test procedures.Of the 505 fresh serum samples, 57 sera were reactive in at least one of the nontreponemal tests. The three sera giving borderline FTA-ABS test results were not entered into the tabulation. See Table 1 for distribution of reactive sera among the three nontreponemal tests and the FTA-ABS test.15

Table 1

Nontreponemal test pattern of reactivitya

No. of sera with pattern

No. of sera with following result by FTA-ABS testa

RPR Card TestVDRL Slide R B NRPR

Test #1Standard

RPR Test #2R R R 43 38 2 3N R R 1 1 – –N N R 4 2 – 2N R N 1 1 – –R R N 5 5 – –R N N 1 1 – –R N R 2 1 1 –

aR, Reactive; B, borderline; N, nonreactive

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Table 2 shows the diagnoses associated with reactive nontreponemal tests.15

Table 2

Stage of Syphilis

No. of sera with indicated reaction by following testa

RPR card testVDRL slide test FTA-ABS Test

Test #1 Standard Test #2R N R N R W N R B N

PrimaryUntreated 5 1 6 – 4 2 – 6 – –Treated 7 1 7 1 5 1 2 8 – –

SecondaryUntreated 6 – 6 – 6 – – 6 – –Treated 5 – 5 – 5 – – 5 – –

LatentUntreated 9 – 8 1 8 – 1 8 1 –Treated 15 1 15 1 10 3 3 14 – 2

Past history of syphilis 1 1 1 1 – 2 – 2 – –Other sexually transmitted diseases 3 2 2 3 3 2 – – 2 3

a R, Reactive; N, nonreactive; W, weakly reactive (considered reactive in tabulation); B, borderline

The sensitivity of all three nontreponemal tests, based on the 21 untreated cases of syphilis was 95.2% (20 out of 21 results in agreement). With the 31 sera from individuals with treated syphilis, the sensitivity of the VDRL slide test was 83.9% (26 out of 31 results in agreement). The overall sensitivity (treated and untreated) was 88.5% for the VDRL slide test, as compared to 92.3% for both RPR card tests.The specificities of the three nontreponemal tests based on the 453 sera drawn from individuals presumed not to have syphilis were 99.3% for RPR Test #1, 99.6% for the standard RPR Test #2 and 98.9% for the VDRL slide test.15

In another study conducted by Pope, Hunter and Feeley16 at the Centers for Disease Control in Atlanta, Georgia, 297 sera were tested by an enzyme-linked immunosorbent assay (ELISA), VDRL slide test, FTA-ABS test and the microhemagglutination assay for T. pallidum antibodies (MHA-TP). Table 3 below lists the sensitivities and specificities of each method published in this study.16

Table 3Test Sensitivity Specificity

ELISA 89.3% 98.5%VDRL 93.3% 92.7%

FTA-ABS 100% 97.8%MHA-TP 76% 98.2%

AVAILABILITYCat. No. Description240764 BD BBL™ VDRL Antigen; 1 x 5 mL Ampules with 1 x 60 mL Saline240765 BD BBL™ VDRL Antigen; 10 x 0.5 mL Ampules with 1 x 60 mL Saline235201 BD BBL™ VDRL Test Control Serum Set, 1 set of 3 vials: Nontreponemal Antigen Reactive Serum, one 3 mL vial VDRL Weakly Reactive Serum, one 3 mL vial Nontreponemal Antigen Nonreactive Serum, one 3 mL vial

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REFERENCES1. Larsen, S.A., V. Pope, R. Johnson, and E.J. Kennedy, Jr. (ed.). 1998. A manual of tests for syphilis, 9th ed. American Public Health

Association, Washington, D.C.2. Creighton, E.T. 1990. Darkfield microscopy for the detection and identification of Treponema pallidum, p. 49–61. In S. A. Larsen,

E. F. Hunter, and S. J. Kraus (ed.), Manual of tests for syphilis, 8th ed. American Public Health Association, Washington, D.C.3. Janda, W.M. (ed.). 1994. Immunology, p. 9.7.1–9.7.20. In H. D. Isenberg (ed.), Clinical microbiology procedures handbook,

vol. 2. American Society for Microbiology, Washington, D.C.4. Norris, S.J., V. Pope, R.E. Johnson and S.A. Larsen. 2003. Treponema and other human host-associated spirochetes,

p. 955–971. In P.R. Murray, E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.), Manual of clinical microbiology, 8th ed. American Society for Microbiology, Washington, D.C.

5. Matthews, H.M., T.K. Yang, and H.M. Jenkin. 1979. Unique lipid composition or Treponema pallidum (Nichols virulent strain). Infect. Immun. 24:713–719.

6. Harris, A., A.A. Rosenberg, and L.M. Riedel. 1946. A microflocculation test for syphilis using cardiolipin antigen. J. Ven. Dis. Infor 27:169–174.

7. Pangborn, M.C. 1941. A new serologically active phospholipid from beef heart. Proc. Soc. Exp. Biol. Med. 48:484:486. 8. Pangborn, M.C. 1944. Acid cardiolipin and an improved method for the preparation of cardiolipin from beef heart. J. Biol. Chem.

153:343–348.9. Pangborn, M.C. 1945. A simplified preparation of cardiolipin, with a note on purification of lecithin for serologic use.

J. Biol. Chem. 161:71–82.10. Clinical and Laboratory Standards Institute. 2005. Approved Guideline M29-A3. Protection of laboratory workers from

occupationally acquired infections, 3rd ed., CLSI, Wayne, PA.11. Garner, J.S. 1996. Hospital Infection Control Practices Advisory Committee, U.S. Department of Health and Human Services,

Centers for Disease Control and Prevention. Guideline for isolation precautions in hospitals. Infect. Control Hospital Epidemol. 17:53–80

12. U.S. Department of Health and Human Services. 2007. Biosafety in microbiological and biomedical laboratories, HHS Publication (CDC) 5th ed. U.S. Government Printing Office, Washington, D.C.

13. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). Official Journal L262, 17/10/2000, p. 0021–0045.

14. Thomson, R.B. and J.M. Miller. 2003. Specimen collection, transport and processing: bacteriology, p. 286–330. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller and R.H. Yolken (ed.), Manual of clinical microbiology, 8th ed. American Society for Microbiology, Washington, D.C.

15. Perryman, M.W., S.A. Larsen, E.A. Hambie, D.E. Pettit, R.L. Mullally and W. Whittington. 1982. Evaluation of a new rapid plasma reagin card test as a screening test for syphilis. J. Clin. Microbiol. 16:286–290.

16 Pope, V., E.F. Hunter and J.C. Feeley. 1982. Evaluation of the microenzyme-linked immunosorbent assay with Treponema pallidum antigen. J. Clin. Microbiol. 15:630–634.

Technical Information: In the United States contact BD Technical Service and Support at 1.800.638.8663 or bd.com.

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Change HistoryRevision Date Change Summary

(07) 2020-05 Converted printed instructions for use to electronic format and added access information to obtain the document from bd.com/e-labeling.Updated Precautionary statements, P241, P240, P233, P242, and P243 added to existing statements, per current Safety Data Sheet for Catalog Numbers 240764 and 240765.Updated Precautionary statements, P270 and P330 added to existing statements, per current Safety Data Sheet for Catalog Number 235201.Updated Australian Sponsor Address, and added New Zealand Sponsor Address.

US Customers only: For symbol glossary, refer to bd.com/symbols-glossary

Manufacturer / Производител / Výrobce / Fabrikant / Hersteller / Κατασκευαστής / Fabricante / Tootja / Fabricant / Proizvođać / Gyártó / Fabbricante / Атқарушы / 제조업체 / Gamintojas / Ražotājs / Tilvirker / Producent / Producător / Производитель / Výrobca / Proizvođač / Tillverkare / Üretici / Виробник / 生产厂商 Use by / Използвайте до / Spotřebujte do / Brug før / Verwendbar bis / Χρήση έως / Usar antes de / Kasutada enne / Date de péremption / 사용 기한 / Upotrijebiti do / Felhasználhatóság dátuma / Usare entro / Дейін пайдалануға / Naudokite iki / Izlietot līdz / Houdbaar tot / Brukes for / Stosować do / Prazo de validade / A se utiliza până la / Использовать до / Použite do / Upotrebiti do / Använd före / Son kullanma tarihi / Використати до\line / 使用截止日期YYYY-MM-DD / YYYY-MM (MM = end of month)ГГГГ-ММ-ДД / ГГГГ-ММ (ММ = края на месеца)RRRR-MM-DD / RRRR-MM (MM = konec měsíce)ÅÅÅÅ-MM-DD / ÅÅÅÅ-MM (MM = slutning af måned)JJJJ-MM-TT / JJJJ-MM (MM = Monatsende)ΕΕΕΕ-MM-HH / ΕΕΕΕ-MM (MM = τέλος του μήνα)AAAA-MM-DD / AAAA-MM (MM = fin del mes)AAAA-KK-PP / AAAA-KK (KK = kuu lõpp)AAAA-MM-JJ / AAAA-MM (MM = fin du mois)GGGG-MM-DD / GGGG-MM (MM = kraj mjeseca)ÉÉÉÉ-HH-NN / ÉÉÉÉ-HH (HH = hónap utolsó napja)AAAA-MM-GG / AAAA-MM (MM = fine mese)ЖЖЖЖ-АА-КК / ЖЖЖЖ-АА / (АА = айдың соңы)YYYY-MM-DD/YYYY-MM(MM = 월말)MMMM-MM-DD / MMMM-MM (MM = mėnesio pabaiga)GGGG-MM-DD/GGGG-MM (MM = mēneša beigas)JJJJ-MM-DD / JJJJ-MM (MM = einde maand)ÅÅÅÅ-MM-DD / ÅÅÅÅ-MM (MM = slutten av måneden)RRRR-MM-DD / RRRR-MM (MM = koniec miesiąca)AAAA-MM-DD / AAAA-MM (MM = fim do mês)AAAA-LL-ZZ / AAAA-LL (LL = sfârşitul lunii)ГГГГ-ММ-ДД / ГГГГ-ММ (ММ = конец месяца)RRRR-MM-DD / RRRR-MM (MM = koniec mesiaca)GGGG-MM-DD / GGGG-MM (MM = kraj meseca)ÅÅÅÅ-MM-DD / ÅÅÅÅ-MM (MM = slutet av månaden)YYYY-AA-GG / YYYY-AA (AA = ayın sonu)РРРР-MM-ДД / РРРР-MM (MM = кінець місяця)YYYY-MM-DD / YYYY-MM (MM = 月末)

Catalog number / Каталожен номер / Katalogové číslo / Katalognummer / Αριθμός καταλόγου / Número de catálogo / Katalooginumber / Numéro catalogue / Kataloški broj / Katalógusszám / Numero di catalogo / Каталог нөмірі / 카탈로그 번호 / Katalogo / numeris / Kataloga numurs / Catalogus nummer / Numer katalogowy / Număr de catalog / Номер по каталогу / Katalógové číslo / Kataloški broj / Katalog numarası / Номер за каталогом / 目录号

Authorized Representative in the European Community / Оторизиран представител в Европейската общност / Autorizovaný zástupce pro Evropském společenství / Autoriseret repræsentant i De Europæiske Fællesskaber / Autorisierter Vertreter in der Europäischen Gemeinschaft / Εξουσιοδοτημένος αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα / Representante autorizado en la Comunidad Europea / Volitatud esindaja Euroopa Nõukogus / Représentant autorisé pour la Communauté européenne / Autorizuirani predstavnik u Europskoj uniji / Meghatalmazott képviselő az Európai Közösségben / Rappresentante autorizzato nella Comunità Europea / Европа қауымдастығындағы уәкілетті өкіл /유럽 공동체의 위임 대표 / Įgaliotasis atstovas Europos Bendrijoje / Pilnvarotais pārstāvis Eiropas Kopienā / Bevoegde vertegenwoordiger in de Europese Gemeenschap / Autorisert representant i EU / Autoryzowane przedstawicielstwo we Wspólnocie Europejskiej / Representante autorizado na Comunidade Europeia / Reprezentantul autorizat pentru Comunitatea Europeană / Уполномоченный представитель в Европейском сообществе / Autorizovaný zástupca v Európskom spoločenstve / Autorizovano predstavništvo u Evropskoj uniji / Auktoriserad representant i Europeiska gemenskapen / Avrupa Topluluğu Yetkili Temsilcisi / Уповноважений представник у країнах ЄС / 欧洲共同体授权代表

In Vitro Diagnostic Medical Device / Медицински уред за диагностика ин витро / Lékařské zařízení určené pro diagnostiku in vitro / In vitro diagnostisk medicinsk anordning / Medizinisches In-vitro-Diagnostikum / In vitro διαγνωστική ιατρική συσκευή / Dispositivo médico para diagnóstico in vitro / In vitro diagnostika meditsiiniaparatuur / Dispositif médical de diagnostic in vitro / Medicinska pomagala za In Vitro Dijagnostiku / In vitro diagnosztikai orvosi eszköz / Dispositivo medicale per diagnostica in vitro / Жасанды жағдайда жүргізетін медициналық диагностика аспабы / In Vitro Diagnostic 의료 기기 / In vitro diagnostikos prietaisas / Medicīnas ierīces, ko lieto in vitro diagnostikā / Medisch hulpmiddel voor in-vitro diagnostiek / In vitro diagnostisk medisinsk utstyr / Urządzenie medyczne do diagnostyki in vitro / Dispositivo médico para diagnóstico in vitro / Dispozitiv medical pentru diagnostic in vitro / Медицинский прибор для диагностики in vitro / Medicínska pomôcka na diagnostiku in vitro / Medicinski uređaj za in vitro dijagnostiku / Medicinteknisk produkt för in vitro-diagnostik / İn Vitro Diyagnostik Tıbbi Cihaz / Медичний пристрій для діагностики in vitro / 体外诊断医疗设备

Temperature limitation / Температурни ограничения / Teplotní omezení / Temperaturbegrænsning / Temperaturbegrenzung / Περιορισμοί θερμοκρασίας / Limitación de temperatura / Temperatuuri piirang / Limites de température / Dozvoljena temperatura / Hőmérsékleti határ / Limiti di temperatura / Температураны шектеу /온도 제한 / Laikymo temperatūra / Temperatūras ierobežojumi / Temperatuurlimiet / Temperaturbegrensning / Ograniczenie temperatury / Limites de temperatura / Limite de temperatură / Ограничение температуры / Ohraničenie teploty / Ograničenje temperature / Temperaturgräns / Sıcaklık sınırlaması / Обмеження температури / 温度限制

Batch Code (Lot) / Код на партидата / Kód (číslo) šarže / Batch-kode (lot) / Batch-Code (Charge) / Κωδικός παρτίδας (παρτίδα) / Código de lote (lote) / Partii kood / Numéro de lot / Lot (kod) / Tétel száma (Lot) / Codice batch (lotto) / Топтама коды / 배치 코드(로트) / Partijos numeris (LOT) / Partijas kods (laidiens) / Lot nummer / Batch-kode (parti) / Kod partii (seria) / Código do lote / Cod de serie (Lot) / Код партии (лот) / Kód série (šarža) / Kod serije / Partinummer (Lot) / Parti Kodu (Lot) / Код партії / 批号（亚批）

Contains sufficient for <n> tests / Съдържанието е достатъчно за <n> теста / Dostatečné množství pro <n> testů / Indeholder tilstrækkeligt til <n> tests / Ausreichend für <n> Tests / Περιέχει επαρκή ποσότητα για <n> εξετάσεις / Contenido suficiente para <n> pruebas / Küllaldane <n> testide jaoks / Contenu suffisant pour <n> tests / Sadržaj za <n> testova / <n> teszthez elegendő / Contenuto sufficiente per <n> test / <п> тесттері үшін жеткілікті / <n> 테스트가 충분히 포함됨 / Pakankamas kiekis atlikti <n> testų / Satur pietiekami <n> pārbaudēm / Inhoud voldoende voor “n” testen / Innholder tilstrekkelig til <n> tester / Zawiera ilość wystarczającą do <n> testów / Conteúdo suficiente para <n> testes / Conţinut suficient pentru <n> teste / Достаточно для <n> тестов(а) / Obsah vystačí na <n> testov / Sadržaj dovoljan za <n> testova / Innehåller tillräckligt för <n> analyser / <n> test için yeterli malzeme içerir / Вистачить для аналізів: <n> / 足够进行 <n> 次检测

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Consult Instructions for Use / Направете справка в инструкциите за употреба / Prostudujte pokyny k použití / Se brugsanvisningen / Gebrauchsanweisung beachten / Συμβουλευτείτε τις οδηγίες χρήσης / Consultar las instrucciones de uso / Lugeda kasutusjuhendit / Consulter la notice d’emploi / Koristi upute za upotrebu / Olvassa el a használati utasítást / Consultare le istruzioni per l’uso / Пайдалану нұсқаулығымен танысып алыңыз / 사용 지침 참조 / Skaitykite naudojimo instrukcijas / Skatīt lietošanas pamācību / Raadpleeg de gebruiksaanwijzing / Se i bruksanvisningen / Zobacz instrukcja użytkowania / Consultar as instruções de utilização / Consultaţi instrucţiunile de utilizare / См. руководство по эксплуатации / Pozri Pokyny na používanie / Pogledajte uputstvo za upotrebu / Se bruksanvisningen / Kullanım Talimatları’na başvurun / Див. інструкції з використання / 请参阅使用说明

Do not reuse / Не използвайте отново / Nepoužívejte opakovaně / Ikke til genbrug / Nicht wiederverwenden / Μην επαναχρησιμοποιείτε / No reutilizar / Mitte kasutada korduvalt / Ne pas réutiliser / Ne koristiti ponovo / Egyszer használatos / Non riutilizzare / Пайдаланбаңыз / 재사용 금지 / Tik vienkartiniam naudojimui / Nelietot atkārtoti / Niet opnieuw gebruiken / Kun til engangsbruk / Nie stosować powtórnie / Não reutilize / Nu refolosiţi / Не использовать повторно / Nepoužívajte opakovane / Ne upotrebljavajte ponovo / Får ej återanvändas / Tekrar kullanmayın / Не використовувати повторно / 请勿重复使用

Serial number / Сериен номер / Sériové číslo / Serienummer / Seriennummer / Σειριακός αριθμός / Nº de serie / Seerianumber / Numéro de série / Serijski broj / Sorozatszám / Numero di serie / Топтамалық нөмірі / 일련 / Serijos numeris / Sērijas numurs / Serie nummer / Numer seryjny /Número de série / Număr de serie / Серийный номер / Seri numarası / Номер серії / 序列号

For IVD Performance evaluation only / Само за оценка качеството на работа на IVD / Pouze pro vyhodnocení výkonu IVD / Kun til evaluering af IVD ydelse / Nur für IVD-Leistungsbewertungszwecke / Mόνο για αξιολόγηση απόδοσης IVD / Sólo para la evaluación del rendimiento en diagnóstico in vitro / Ainult IVD seadme hindamiseks / Réservé à l’évaluation des performances IVD / Samo u znanstvene svrhe za In Vitro Dijagnostiku / Kizárólag in vitro diagnosztikához / Solo per valutazione delle prestazioni IVD / Жасанды жағдайда «пробирка ішінде»,диагностикада тек жұмысты бағалау үшін / IVD 성능 평가에 대해서만 사용 / Tik IVD prietaisų veikimo charakteristikoms tikrinti / Vienīgi IVD darbības novērtēšanai /Uitsluitend voor doeltreffendheidsonderzoek / Kun for evaluering av IVD-ytelse / Tylko do oceny wydajności IVD / Uso exclusivo para avaliação de IVD / Numai pentru evaluarea performanţei IVD / Только для оценки качества диагностики in vitro / Určené iba na diagnostiku in vitro / Samo za procenu učinka u in vitro dijagnostici / Endast för utvärdering av diagnostisk användning in vitro / Yalnızca IVD Performans değerlendirmesi için / Тільки для оцінювання якості діагностики in vitro / 仅限 IVD 性能评估 For US: “For Investigational Use Only”Lower limit of temperature / Долен лимит на температурата / Dolní hranice teploty / Nedre temperaturgrænse / Temperaturuntergrenze / Κατώτερο όριο θερμοκρασίας / Límite inferior de temperatura / Alumine temperatuuripiir / Limite inférieure de température / Najniža dozvoljena temperatura / Alsó hőmérsékleti határ / Limite inferiore di temperatura / Температураның төменгі руқсат шегі / 하한 온도 / Žemiausia laikymo temperatūra / Temperatūras zemākā robeža /Laagste temperatuurlimiet / Nedre temperaturgrense / Dolna granica temperatury / Limite minimo de temperatura / Limită minimă de temperatură / Нижний предел температуры / Spodná hranica teploty / Donja granica temperature / Nedre temperaturgräns / Sıcaklık alt sınırı / Мінімальна температура / 温度下限

Control / Контролно / Kontrola / Kontrol / Kontrolle / Μάρτυρας / Kontroll / Contrôle / Controllo / Бақылау / 컨트롤 / Kontrolė / Kontrole / Controle / Controlo / Контроль / kontroll / Контроль / 对照

Positive control / Положителен контрол / Pozitivní kontrola / Positiv kontrol / Positive Kontrolle / Θετικός μάρτυρας / Control positivo / Positiivne kontroll / Contrôle positif / Pozitivna kontrola / Pozitív kontroll / Controllo positivo / Оң бақылау / 양성 컨트롤 / Teigiama kontrolė / Pozitīvā kontrole / Positieve controle / Kontrola dodatnia / Controlo positivo / Control pozitiv / Положительный контроль / Pozitif kontrol / Позитивний контроль / 阳性对照试剂

Negative control / Отрицателен контрол / Negativní kontrola / Negativ kontrol / Negative Kontrolle / Αρνητικός μάρτυρας / Control negativo / Negatiivne kontroll / Contrôle négatif / Negativna kontrola / Negatív kontroll / Controllo negativo / Негативтік бақылау / 음성 컨트롤 / Neigiama kontrolė / Negatīvā kontrole / Negatieve controle / Kontrola ujemna / Controlo negativo / Control negativ / Отрицательный контроль / Negatif kontrol / Негативний контроль / 阴性对照试剂

Method of sterilization: ethylene oxide / Метод на стерилизация: етиленов оксид / Způsob sterilizace: etylenoxid / Steriliseringsmetode: ethylenoxid / Sterilisationsmethode: Ethylenoxid / Μέθοδος αποστείρωσης: αιθυλενοξείδιο / Método de esterilización: óxido de etileno / Steriliseerimismeetod: etüleenoksiid / Méthode de stérilisation : oxyde d’éthylène / Metoda sterilizacije: etilen oksid / Sterilizálás módszere: etilén-oxid / Metodo di sterilizzazione: ossido di etilene / Стерилизация әдісі – этилен тотығы / 소독 방법: 에틸렌옥사이드 / Sterilizavimo būdas: etileno oksidas / Sterilizēšanas metode: etilēnoksīds / Gesteriliseerd met behulp van ethyleenoxide / Steriliseringsmetode: etylenoksid / Metoda sterylizacji: tlenek etylu / Método de esterilização: óxido de etileno / Metodă de sterilizare: oxid de etilenă / Метод стерилизации: этиленоксид / Metóda sterilizácie: etylénoxid / Metoda sterilizacije: etilen oksid / Steriliseringsmetod: etenoxid / Sterilizasyon yöntemi: etilen oksit / Метод стерилізації: етиленоксидом / 灭菌方法：环氧乙烷

Method of sterilization: irradiation / Метод на стерилизация: ирадиация / Způsob sterilizace: záření / Steriliseringsmetode: bestråling / Sterilisationsmethode: Bestrahlung / Μέθοδος αποστείρωσης: ακτινοβολία / Método de esterilización: irradiación / Steriliseerimismeetod: kiirgus / Méthode de stérilisation : irradiation / Metoda sterilizacije: zračenje / Sterilizálás módszere: besugárzás / Metodo di sterilizzazione: irradiazione / Стерилизация әдісі – сәуле түсіру / 소독 방법: 방사 / Sterilizavimo būdas: radiacija / Sterilizēšanas metode: apstarošana / Gesteriliseerd met behulp van bestraling / Steriliseringsmetode: bestråling / Metoda sterylizacji: napromienianie / Método de esterilização: irradiação / Metodă de sterilizare: iradiere / Метод стерилизации: облучение / Metóda sterilizácie: ožiarenie / Metoda sterilizacije: ozračavanje / Steriliseringsmetod: strålning / Sterilizasyon yöntemi: irradyasyon / Метод стерилізації: опроміненням / 灭菌方法：辐射

Biological Risks / Биологични рискове / Biologická rizika / Biologisk fare / Biogefährdung / Βιολογικοί κίνδυνοι / Riesgos biológicos / Bioloogilised riskid / Risques biologiques / Biološki rizik / Biológiailag veszélyes / Rischio biologico / Биологиялық тәуекелдер / 생물학적 위험 / Biologinis pavojus / Bioloģiskie riski / Biologisch risico / Biologisk risiko / Zagrożenia biologiczne / Perigo biológico / Riscuri biologice / Биологическая опасность / Biologické riziko / Biološki rizici / Biologisk risk / Biyolojik Riskler / Біологічна небезпека / 生物学风险

Caution, consult accompanying documents / Внимание, направете справка в придружаващите документи / Pozor! Prostudujte si přiloženou dokumentaci! / Forsigtig, se ledsagende dokumenter / Achtung, Begleitdokumente beachten / Προσοχή, συμβουλευτείτε τα συνοδευτικά έγγραφα / Precaución, consultar la documentación adjunta / Ettevaatust! Lugeda kaasnevat dokumentatsiooni / Attention, consulter les documents joints / Upozorenje, koristi prateču dokumentaciju / Figyelem! Olvassa el a mellékelt tájékoztatót / Attenzione: consultare la documentazione allegata / Абайлаңыз, тиісті құжаттармен танысыңыз / 주의, 동봉된 설명서 참조 / Dėmesio, žiūrėkite pridedamus dokumentus / Piesardzība, skatīt pavaddokumentus / Voorzichtig, raadpleeg bijgevoegde documenten / Forsiktig, se vedlagt dokumentasjon / Należy zapoznać się z dołączonymi dokumentami / Cuidado, consulte a documentação fornecida / Atenţie, consultaţi documentele însoţitoare / Внимание: см. прилагаемую документацию / Výstraha, pozri sprievodné dokumenty / Pažnja! Pogledajte priložena dokumenta / Obs! Se medföljande dokumentation / Dikkat, birlikte verilen belgelere başvurun / Увага: див. супутню документацію / 小心，请参阅附带文档。

Upper limit of temperature / Горен лимит на температурата / Horní hranice teploty / Øvre temperaturgrænse / Temperaturobergrenze / Ανώτερο όριο θερμοκρασίας / Límite superior de temperatura / Ülemine temperatuuripiir / Limite supérieure de température / Gornja dozvoljena temperatura / Felső hőmérsékleti határ / Limite superiore di temperatura / Температураның руқсат етілген жоғарғы шегі / 상한 온도 / Aukščiausia laikymo temperatūra / Augšējā temperatūras robeža / Hoogste temperatuurlimiet / Øvre temperaturgrense / Górna granica temperatury / Limite máximo de temperatura / Limită maximă de temperatură / Верхний предел температуры / Horná hranica teploty / Gornja granica temperature / Övre temperaturgräns / Sıcaklık üst sınırı / Максимальна температура / 温度上限

Keep dry / Пазете сухо / Skladujte v suchém prostředí / Opbevares tørt / Trocklagern / Φυλάξτε το στεγνό / Mantener seco / Hoida kuivas / Conserver au sec / Držati na suhom / Száraz helyen tartandó / Tenere all’asciutto / Құрғақ күйінде ұста / 건조 상태 유지 / Laikykite sausai / Uzglabāt sausu / Droog houden / Holdes tørt / Przechowywać w stanie suchym / Manter seco / A se feri de umezeală / Не допускать попадания влаги / Uchovávajte v suchu / Držite na suvom mestu / Förvaras torrt / Kuru bir şekilde muhafaza edin / Берегти від вологи / 请保持干燥

Collection time / Време на събиране / Čas odběru / Opsamlingstidspunkt / Entnahmeuhrzeit / Ώρα συλλογής / Hora de recogida / Kogumisaeg / Heure de prélèvement / Sati prikupljanja / Mintavétel időpontja / Ora di raccolta / Жинау уақыты / 수집 시간 / Paėmimo laikas / Savākšanas laiks / Verzameltijd / Tid prøvetaking / Godzina pobrania / Hora de colheita / Ora colectării / Время сбора / Doba odberu / Vreme prikupljanja / Uppsamlingstid / Toplama zamanı / Час забору / 采集时间

Peel / Обелете / Otevřete zde / Åbn / Abziehen / Αποκολλήστε / Desprender / Koorida / Décoller / Otvoriti skini / Húzza le / Staccare / Ұстіңгі қабатын алып таста / 벗기기 / Plėšti čia / Atlīmēt / Schillen / Trekk av / Oderwać / Destacar / Se dezlipeşte / Отклеить / Odtrhnite / Oljuštiti / Dra isär / Ayırma / Відклеїти / 撕下

Perforation / Перфорация / Perforace / Perforering / Διάτρηση / Perforación / Perforatsioon / Perforacija / Perforálás / Perforazione / Тесік тесу / 절취선 / Perforacija / Perforācija / Perforatie / Perforacja / Perfuração / Perforare / Перфорация / Perforácia / Perforasyon / Перфорація / 穿孔

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Do not use if package damaged / Не използвайте, ако опаковката е повредена / Nepoužívejte, je-li obal poškozený / Må ikke anvendes hvis emballagen er beskadiget / Inhal beschädigter Packungnicht verwenden / Μη χρησιμοποιείτε εάν η συσκευασία έχει υποστεί ζημιά. / No usar si el paquete está dañado / Mitte kasutada, kui pakend on kahjustatud / Ne pas l’utiliser si l’emballage est endommagé / Ne koristiti ako je oštećeno pakiranje / Ne használja, ha a csomagolás sérült / Non usare se la confezione è danneggiata / Егер пакет бұзылған болса, пайдаланба / 패키지가 손상된 경우 사용 금지 / Jei pakuotė pažeista, nenaudoti / Nelietot, ja iepakojums bojāts / Niet gebruiken indien de verpakking beschadigd is / Må ikke brukes hvis pakke er skadet / Nie używać, jeśli opakowanie jest uszkodzone / Não usar se a embalagem estiver danificada / A nu se folosi dacă pachetul este deteriorat / Не использовать при повреждении упаковки / Nepoužívajte, ak je obal poškodený / Ne koristite ako je pakovanje oštećeno / Använd ej om förpackningen är skadad / Ambalaj hasar görmüşse kullanmayın / Не використовувати за пошкодженої упаковки / 如果包装破损，请勿使用

Keep away from heat / Пазете от топлина / Nevystavujte přílišnému teplu / Må ikke udsættes for varme / Vor Wärme schützen / Κρατήστε το μακριά από τη θερμότητα / Mantener alejado de fuentes de calor / Hoida eemal valgusest / Protéger de la chaleur / Držati dalje od izvora topline / Óvja a melegtől / Tenere lontano dal calore / Салқын жерде сақта / 열을 피해야 함 / Laikyti atokiau nuo šilumos šaltinių / Sargāt no karstuma / Beschermen tegen warmte / Må ikke utsettes for varme / Przechowywać z dala od źródeł ciepła / Manter ao abrigo do calor / A se feri de căldură / Не нагревать / Uchovávajte mimo zdroja tepla / Držite dalje od toplote / Får ej utsättas för värme / Isıdan uzak tutun / Берегти від дії тепла / 请远离热源

Cut / Срежете / Odstřihněte / Klip / Schneiden / Κόψτε / Cortar / Lõigata / Découper / Reži / Vágja ki / Tagliare / Кесіңіз / 잘라내기 / Kirpti / Nogriezt / Knippen / Kutt / Odciąć / Cortar / Decupaţi / Отрезать / Odstrihnite / Iseći / Klipp / Kesme / Розрізати / 剪下

Collection date / Дата на събиране / Datum odběru / Opsamlingsdato / Entnahmedatum / Ημερομηνία συλλογής / Fecha de recogida / Kogumiskuupäev / Date de prélèvement / Dani prikupljanja / Mintavétel dátuma / Data di raccolta / Жинаған тізбекүні / 수집 날짜 / Paėmimo data / Savākšanas datums / Verzameldatum / Dato prøvetaking / Data pobrania / Data de colheita / Data colectării / Дата сбора / Dátum odberu / Datum prikupljanja / Uppsamlingsdatum / Toplama tarihi / Дата забору / 采集日期

µL/test / µL/тест / µL/Test / µL/εξέταση / µL/prueba / µL/teszt / µL/테스트 / мкл/тест / µL/tyrimas / µL/pārbaude / µL/teste / мкл/аналіз / µL/检测

Keep away from light / Пазете от светлина / Nevystavujte světlu / Må ikke udsættes for lys / Vor Licht schützen / Κρατήστε το μακριά από το φως / Mantener alejado de la luz / Hoida eemal valgusest / Conserver à l’abri de la lumière / Držati dalje od svjetla / Fény nem érheti / Tenere al riparo dalla luce / Қараңғыланған жерде ұста / 빛을 피해야 함 / Laikyti atokiau nuo šilumos šaltinių / Sargāt no gaismas / Niet blootstellen aan zonlicht / Må ikke utsettes for lys / Przechowywać z dala od źródeł światła / Manter ao abrigo da luz / Feriţi de lumină / Хранить в темноте / Uchovávajte mimo dosahu svetla / Držite dalje od svetlosti / Får ej utsättas för ljus / Işıktan uzak tutun / Берегти від дії світла / 请远离光线

Hydrogen gas generated / Образуван е водород газ / Možnost úniku plynného vodíku / Frembringer hydrogengas / Wasserstoffgas erzeugt / Δημιουργία αερίου υδρογόνου / Producción de gas de hidrógeno / Vesinikgaasi tekitatud / Produit de l’hydrogène gazeux / Sadrži hydrogen vodik / Hidrogén gázt fejleszt / Produzione di gas idrogeno / Газтектес сутегі пайда болды / 수소 가스 생성됨 / Išskiria vandenilio dujas / Rodas ūdeņradis / Waterstofgas gegenereerd / Hydrogengass generert / Powoduje powstawanie wodoru / Produção de gás de hidrogénio / Generare gaz de hidrogen / Выделение водорода / Vyrobené použitím vodíka / Oslobađa se vodonik / Genererad vätgas / Açığa çıkan hidrojen gazı / Реакція з виділенням водню / 会产生氢气

Patient ID number / ИД номер на пациента / ID pacienta / Patientens ID-nummer / Patienten-ID / Αριθμός αναγνώρισης ασθενούς / Número de ID del paciente / Patsiendi ID / No d’identification du patient / Identifikacijski broj pacijenta / Beteg azonosító száma / Numero ID paziente / Пациенттің идентификациялық нөмірі / 환자 ID 번호 / Paciento identifikavimo numeris / Pacienta ID numurs / Identificatienummer van de patiënt / Pasientens ID-nummer / Numer ID pacjenta / Número da ID do doente / Număr ID pacient / Идентификационный номер пациента / Identifikačné číslo pacienta / ID broj pacijenta / Patientnummer / Hasta kimlik numarası / Ідентифікатор пацієнта / 患者标识号

Fragile, Handle with Care / Чупливо, Работете с необходимото внимание. / Křehké. Při manipulaci postupujte opatrně. / Forsigtig, kan gå i stykker. / Zerbrechlich, vorsichtig handhaben. / Εύθραυστο. Χειριστείτε το με προσοχή. / Frágil. Manipular con cuidado. / Õrn, käsitsege ettevaatlikult. / Fragile. Manipuler avec précaution. / Lomljivo, rukujte pažljivo. / Törékeny! Óvatosan kezelendő. / Fragile, maneggiare con cura. / Сынғыш, абайлап пайдаланыңыз. / 조심 깨지기 쉬운 처리 / Trapu, elkitės atsargiai. / Trausls; rīkoties uzmanīgi / Breekbaar, voorzichtig behandelen. / Ømtålig, håndter forsiktig. / Krucha zawartość, przenosić ostrożnie. / Frágil, Manuseie com Cuidado. / Fragil, manipulaţi cu atenţie. / Хрупкое! Обращаться с осторожностью. / Krehké, vyžaduje sa opatrná manipulácia. / Lomljivo - rukujte pažljivo. / Bräckligt. Hantera försiktigt. / Kolay Kırılır, Dikkatli Taşıyın. / Тендітна, звертатися з обережністю / 易碎，小心轻放

This only applies to US: “Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.” / S’applique uniquement aux États-Unis: “Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.” / Vale solo per gli Stati Uniti: “Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.” / Gilt nur für die USA: “Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.” / Sólo se aplica a los EE.UU.: “Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.”

Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA

Benex Limited Pottery Road, Dun Laoghaire Co. Dublin, Ireland

Australian Sponsor:Becton Dickinson Pty Ltd.66 Waterloo RoadMacquarie Park NSW 2113 Australia

New Zealand Sponsor:Becton Dickinson Limited14B George Bourke DriveMt. Wellington Auckland 1060New Zealand

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Europe, CH, GB, NO:International:

+800 135 79 135+31 20 794 7071

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